A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Cohort I (DTG 50 mg OD)

Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).

Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences [ Time Frame: From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II) ]

Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences

Measure Description

The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

Time Frame

From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.

Reporting Groups

Description

Cohort I (DTG 50 mg OD)

Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).

Cohort II (DTG 50 mg BID)

Participants received DTG 50 mg twice a day (BID).

Measured Values

Cohort I (DTG 50 mg OD)

Cohort II (DTG 50 mg BID)

Participants Analyzed [Units: Participants]

27

24

Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences [Units: Participants]

Category B, Candidiasis, oropharyngeal

3

2

Category B, Hairy leukoplakia, oral

2

0

Category B, Herpes Zoster

2

0

Category C, Herpes simplex

1

0

Category C, Candidiasis, esophageal

0

1

Category C, Cytomegalovirus retinitis

0

1

Category C, Kaposi's sarcoma

1

0

Category C, Lymphoma, Burkitt's

0

1

Category C, Lymphoma, immunoblastic

1

0

Death, Brain mass

1

0

Death, Completed suicide

0

1

Death, Febrile bone marrow aplasia

1

0

Death, Immunoblastic lymphoma

1

0

Death, Acute pulmonary oedema

1

0

Death, Anaemia

0

1

Death, Haemochromatosis

0

1

Death, Hepatic fibrosis

0

1

Other: Cryptosporidiosis, acute intestinal

0

1

Other: leukoplasia of both side of the tongue

1

0

No statistical analysis provided for Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences

11. Secondary:

Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death [ Time Frame: From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II) ]

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance [ Time Frame: From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II) ]

Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance [ Time Frame: From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II) ]

Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities [ Time Frame: From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II ]

Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities [ Time Frame: From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.